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Biologics Quality Control Section Head

EVA pharma

Location6th of October, Cairo, Egypt
Job TypeFull-time
Work ModeN/A
SalaryNot specified
Posted

JOBLYIN SUMMARY

Job Overview

This position is offered by EVA pharma, in 6th of October, Cairo, Egypt, as a Full-time role. The job details and listed requirements below are based on the original job posting.

COMPANY PROFILE

About the Company

AIThis summary was prepared with the assistance of AI based on available information and may not reflect all details about the company.

EVA pharma appears to be involved in pharmaceuticals, likely focusing on oncology and immunology with market access roles. It may also engage in civil engineering projects.

ORIGINAL JOB DESCRIPTION

About the Job

Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members. Job Summary We are seeking an experienced Biologics QC Section Head to lead laboratory operations, ensuring the quality, safety, and compliance of biological and biosimilar products through robust analytical testing and biological activity assessment. Key Responsibilities: Lead QC testing and characterization of biological and biosimilar products in compliance with GMP requirements and approved specifications Oversee analytical testing using LC-MS/QTOF, HPLC, ELISA, IEF, SDS-PAGE, and microplate readers Lead bioassay testing for biological activity and potency, including assay execution, data interpretation, troubleshooting, and validation, ensuring reliable and scientifically sound results Manage analytical method transfer, verification, validation, and troubleshooting for new and existing products Review analytical data and lead investigations into OOS/OOT results, deviations, and laboratory incidents, ensuring effective root-cause analysis and CAPA implementation Oversee stability testing and evaluation of biological product stability data Ensure compliance with GMP, data integrity requirements, and applicable regulatory standards Lead and develop the QC team, ensuring timely testing, laboratory efficiency, and continuous improvement Support internal and external audits and regulatory inspections Requirements Bachelor's degree in Science, Biochemistry, Biotechnology, or a related field 6+ years of experience in quality control or quality assurance within the pharmaceutical or related industry Hands-on experience in bioassay testing, biological activity and potency assessment, and assay validation is essential Practical experience with LC-MS/QTOF, HPLC, ELISA, IEF, SDS-PAGE, and microplate reader-based techniques Strong knowledge of GMP, data integrity, laboratory investigations, and pharmaceutical quality systems Previous experience in team leadership or supervision is preferred Show more

CAREER PROFILE

Role Overview

AIThis summary was prepared with the assistance of AI based on available information and may not reflect all details about the company.

The Biologics Quality Control Section Head oversees quality assurance processes for biologic products. This role ensures compliance with regulatory standards and maintains product integrity throughout manufacturing.

JOB SOURCE

Original Job Listing

This job was found through LinkedIn. You can review the original listing before applying.

View Original Listing ↗

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